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    Clinical Trial Results:
    A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 and 6 Infection Without Cirrhosis

    Summary
    EudraCT number
    		 2015-004200-38
    Trial protocol
    		 DE   BE   PL   IT  
    Global end of trial date
    16 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2018
    First version publication date
    31 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    64294178HPC2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02765490
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy, that is, the sustained virologic response 12 weeks (SVR) after the end of the treatment (EOT) (SVR12) of a combination treatment with AL-335, odalasvir (ODV), and simeprevir (SMV) for 6 and 8 weeks in chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. The safety assessments included Physical Examinations, Electrocardiograms (ECG's), Echocardiography, Vital Signs (pulse/heart rate and blood pressure) and Clinical Laboratory Tests.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Nov 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 81
    Country: Number of subjects enrolled
    Canada: 63
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Spain: 58
    Country: Number of subjects enrolled
    Italy: 53
    Country: Number of subjects enrolled
    Poland: 61
    Country: Number of subjects enrolled
    Singapore: 17
    Worldwide total number of subjects
    365
    EEA total number of subjects
    285
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    342
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 365 subjects (183 subjects in Arm A and 182 subjects in Arm B) were enrolled and treated in the study. Out of them 361 subjects (182 subjects in Arm A and 179 subjects in Arm B) completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks
    Arm description
    		 Subjects received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AL-335
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received AL-335 800 mg (2*400) tablets qd in the morning for 6 weeks.

    Investigational medicinal product name
    Odalasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Odalasvir 25 mg tablet qd in the morning for 6 weeks.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 75 mg capsule qd in the morning for 6 weeks.

    Arm title
    		 Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Arm description
    		 Subjects received AL-335 800 mg (2*400) tablets, Odalasvir 25 mg tablet, and Simeprevir 75 mg capsule qd orally in the morning for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AL-335
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received AL-335 800 mg (2*400) tablets qd in the morning for 8 weeks.

    Investigational medicinal product name
    Odalasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Odalasvir 25 mg tablet qd in the morning for 8 weeks.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 75 mg capsule qd in the morning for 8 weeks.

    Number of subjects in period 1
    		Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Started
    183
    182
    Completed
    182
    179
    Not completed
    1
    3
         Death
    -
    1
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks
    Reporting group description
    		 Subjects received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.

    Reporting group title
    Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Reporting group description
    		 Subjects received AL-335 800 mg (2*400) tablets, Odalasvir 25 mg tablet, and Simeprevir 75 mg capsule qd orally in the morning for 8 weeks.

    Reporting group values
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks Total
    Number of subjects
    		 183 182 365
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    		 175 167 342
        From 65 to 84 years
    		 8 15 23
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    		 48 (19 to 69) 49 (18 to 70) -
    Title for Gender
    Units: subjects
        Female
    		 88 94 182
        Male
    		 95 88 183

    End points

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    End points reporting groups
    Reporting group title
    Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks
    Reporting group description
    		 Subjects received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.

    Reporting group title
    Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Reporting group description
    		 Subjects received AL-335 800 mg (2*400) tablets, Odalasvir 25 mg tablet, and Simeprevir 75 mg capsule qd orally in the morning for 8 weeks.

    Primary: Percentage of Subjects With Sustained Virologic Response 12 Weeks after End of Treatment (EOT) (SVR12)

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks after End of Treatment (EOT) (SVR12) [1]
    End point description
    The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT. Intent-To-Treat (ITT) population included all randomized subjects who took at least 1 dose of the study drug [that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)].
    End point type
    Primary
    End point timeframe
    Week 12 (Follow-Up Phase)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistical analysis was performed for this endpoint.
    End point values
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Number of subjects analysed
    183
    182
    Units: Percentage of subjects
        number (confidence interval 95%)
    98.9 (96.1 to 99.9)
    97.8 (94.5 to 99.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
    End point description
    The SVR24 was defined as HCV RNA <LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT). ITT population included all randomized subjects who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV). Last Observation Carried Forward (LOCF) method was used to impute the missing values.
    End point type
    Secondary
    End point timeframe
    Week 24 (Follow-Up Phase)
    End point values
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Number of subjects analysed
    183
    182
    Units: Percentage of subjects
        number (confidence interval 95%)
    98.9 (96.1 to 99.9)
    97.3 (93.7 to 99.1)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Viral Relapse

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    End point title
    		 Number of Subjects With Viral Relapse
    End point description
    Viral Relapse: Subjects who did not achieve SVR12, with HCV RNA <LLOQ at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up. ITT population included all randomized subjects who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV).
    End point type
    Secondary
    End point timeframe
    End of Treatment up to Week 24 (Follow up phase)
    End point values
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Number of subjects analysed
    183
    182
    Units: Subjects
    1
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects With Late Viral Relapse

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    End point title
    		 Number of Subjects With Late Viral Relapse
    End point description
    Late Viral Relapse: Subjects who achieved SVR12 but had confirmed HCV RNA >=LLOQ afterwards during follow-up. ITT population included all randomized subjects who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV).
    End point type
    Secondary
    End point timeframe
    Up to Week 24 (Follow-up Phase)
    End point values
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Number of subjects analysed
    183
    182
    Units: Subjects
    0
    1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With On-treatment Failure

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    End point title
    		 Percentage of Subjects With On-treatment Failure
    End point description
    On-treatment failure: Subjects who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT). ITT population included all randomized subjects who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV).
    End point type
    Secondary
    End point timeframe
    EOT up to Week 12 (Follow up Phase)
    End point values
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Number of subjects analysed
    183
    182
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response 4 Weeks after End of Treatment (EOT)

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 4 Weeks after End of Treatment (EOT)
    End point description
    The SVR 4 was defined as subjects who were considered to reach SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable). ITT population included all randomized subjects who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV).
    End point type
    Secondary
    End point timeframe
    Week 4 (Follow-Up Phase)
    End point values
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Number of subjects analysed
    183
    182
    Units: Percentage of subjects
        number (confidence interval 95%)
    99.5 (97.0 to 100.0)
    98.4 (95.3 to 99.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to Follow-up (Week 24)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks
    Reporting group description
    		 Subjects received AL-335 800 milligram (mg) (2*400) tablets, Odalasvir (ODV) 25 mg tablet, and Simeprevir (SMV) 75 mg capsule once daily (qd) orally in the morning for 6 weeks.

    Reporting group title
    Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Reporting group description
    		 Subjects received AL-335 800 mg (2*400) tablets, Odalasvir 25 mg tablet, and Simeprevir 75 mg capsule qd orally in the morning for 8 weeks.

    Serious adverse events
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 183 (3.83%)
    4 / 182 (2.20%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Breast Neoplasm
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    IVth Nerve Paresis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal Obstruction
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Strangulation
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Choking
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 183 (0.55%)
    0 / 182 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infective Keratitis
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 183 (0.00%)
    1 / 182 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 6 Weeks Arm B: AL-335 800 mg+ODV 25 mg+SMV 75 mg qd for 8 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    83 / 183 (45.36%)
    85 / 182 (46.70%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    40 / 183 (21.86%)
    40 / 182 (21.98%)
         occurrences all number
    63
    49
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 183 (6.01%)
    8 / 182 (4.40%)
         occurrences all number
    11
    9
    Fatigue
         subjects affected / exposed
    27 / 183 (14.75%)
    21 / 182 (11.54%)
         occurrences all number
    30
    22
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 183 (3.83%)
    10 / 182 (5.49%)
         occurrences all number
    8
    13
    Nausea
         subjects affected / exposed
    13 / 183 (7.10%)
    5 / 182 (2.75%)
         occurrences all number
    16
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    15 / 183 (8.20%)
    15 / 182 (8.24%)
         occurrences all number
    16
    16
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    8 / 183 (4.37%)
    12 / 182 (6.59%)
         occurrences all number
    9
    13
    Myalgia
         subjects affected / exposed
    10 / 183 (5.46%)
    13 / 182 (7.14%)
         occurrences all number
    12
    17
    Infections and infestations
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    13 / 183 (7.10%)
    19 / 182 (10.44%)
         occurrences all number
    15
    21

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2016
    The overall reason for the amendment is to change in design of the Phase 2b study with focus on evaluating the 3 Direct-Acting Antiviral Agent (DAA) treatment regimen comprising of AL-335+Odalasvir (ODV) with Simeprevir (SMV).
    12 Aug 2016
    The overall reason for the amendment is to change in design of the Phase 2b study with focus on treatment-naive and treatment-experienced hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
    10 Apr 2017
    The overall reason for the amendment is to implement study treatment stopping rules upon Health Authority feedback. In addition, as more subjects have been recruited than originally planned for, the actual number of subjects enrolled in the study is added and statistical considerations for safety are adjusted accordingly.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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